POLITICO’s Morning eHealth bulletin recently featured Alan Portela, CEO of AirStrip. AirStrip’s Remote Patient Monitoring (RPM) solution (including AirStrip RPM CRITICAL CARE and AirStrip RPM CARDIOLOGY) received FDA clearance as a Class II, 510K device in 2010, making it one of the first mobile medical creations to do so. Today, as FDA health IT regulations are the focus of many debates within the health care and technology sectors, Portela speaks to mobile health innovators seeking regulatory shortcuts. “Don’t do it in health care,” says Portela. “Don’t do it in places where lives are at risk.”
Full bulletin below:
“SOME SKIRT FDA MOBILE APP GUIDELINES; OTHERS WELCOME REGULATION: FDA’s regulation process can be a long, sometimes grueling process. Who would volunteer if there was a shortcut around it? Alan Portela, CEO of Airstrip, that’s who. His company makes a device that monitors patient health measures remotely and was one of the first mobile medical creations to get clearance from the Food and Drug Administration as a Class II, 510K device, back in 2010. Today, FDA medical device software guidance provokes hot debate. Some argue that it is too strict and hinders innovation; other that it doesn’t go far enough. A third group says it’s just right. And a fourth feels that FDA still hasn’t been specific enough about what kinds of health IT will or won’t be regulated. Portela’s advice for mobile health innovators is simple. If you don’t want to be regulated, don’t make products or apps that cross that line. “If people want to take shortcuts, don’t do it in health care,” he said. “Don’t do it in places where lives are at risk.”"
View the bulletin on POLITICO’s website: http://politico.pro/